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Effect of Ketone Ester Supplementation on Sleep and Recovery in Hypoxia

NCT ID: NCT06060093

Last Updated: 2023-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-20

Study Completion Date

2023-03-31

Brief Summary

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This study specifically aims to elucidate the effects of IEK on sleep and recuperation in hypoxia, after training in normoxia. These conditions are in line with the widely applied live-high train-low strategy. Moreover, blood and tissue oxygenation status, as well as cerebral blood flow and cognitive function will be assessed.

Detailed Description

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During training stages in order to prepare for an important event, sleep and recuperation are almost equally important as the appropriate training strategy. This training strategy often consists of living-high (sleeping at -stimulated- altitude) and training low (training at sea level). A decreased oxygen availability, also known as hypoxia, however often disrupts sleep quality and thus compromises the overall training efficiency. Ketones are recently found to improve sleep quality, thus potentially playing a pivotal role in altitude training. Therefore, the investigators want to evaluate the effects of ketones on sleep in hypoxia, after training in normoxia. Moreover, the effect on a performance test, during a simulated 30 min time trial on the next morning, will be investigated. During this protocol, cerebral blood flow will be assessed, as well as ventilation, blood and tissue oxygen status, heart rate variability, and cognitive function.

Conditions

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Ketosis Hypoxia Sleep

Keywords

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Exercise Ketones Living-high Training-low

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

1 session with both training and sleep in normoxia, supplemented with placebo (NPL)

1 session with training in normoxia, sleep in hypoxia, supplemented with placebo (HPL)

1 session with training in normoxia, sleep in hypoxia, supplemented with ketones (HKE)
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Normoxia - placebo

Both training and sleep in normoxia, supplemented with placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Water, 5% collagen(w/w), octoacetate (1 mM)

Hypoxia - placebo

Training in normoxia and sleep in hypoxia, supplemented with placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DIETARY_SUPPLEMENT

Water, 5% collagen(w/w), octoacetate (1 mM)

Hypoxia - ketones

Training in normoxia and sleep in hypoxia, supplemented with ketones

Group Type EXPERIMENTAL

Ketone ester

Intervention Type DIETARY_SUPPLEMENT

A total of 75g ketone ester supplementation will be administered in 3 bouts of 25g in order to establish intermittent exogenous ketosis: twice immediately after training, and one 30 minutes before sleep. The ketone ester used is (R)-3-hydroxybutyl (R)-3-hydroxybutyrate

Interventions

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Placebo

Water, 5% collagen(w/w), octoacetate (1 mM)

Intervention Type DIETARY_SUPPLEMENT

Ketone ester

A total of 75g ketone ester supplementation will be administered in 3 bouts of 25g in order to establish intermittent exogenous ketosis: twice immediately after training, and one 30 minutes before sleep. The ketone ester used is (R)-3-hydroxybutyl (R)-3-hydroxybutyrate

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Written informed consent must be obtained prior to any experimental procedures
2. Males between 18 and 35 years old
3. Recreational or competitive cyclists performing regular cycling training sessions with an average training volume of more than 6 hours per week
4. Good health status confirmed by a medical screening
5. Body Mass Index (BMI) between 18 and 25
6. Normal sleep pattern as assessed by the Pittsburgh Sleep Quality Index
7. Moderate sleep chronotype (extreme morning and evening chronotypes will be excluded), assessed by the Horne and Östberg questionnaire

Exclusion Criteria

1. Any kind of injury/pathology that is a contra-indication for hypoxic exposure and/or to perform high-intensity exercise, evaluated by a sport medical screening
2. Intake of any medication or nutritional supplement that is known to affect exercise, performance or sleep. Intake will be assessed during recruitment and the sport medical screening.
3. Intake of analgesics, anti-inflammatory agents, or supplementary anti-oxidants, from 2 weeks prior to the start of the study.
4. Recent residence or training under hypoxia; more than 7 days exposure to altitude \> 1500m during the last 3 months preceding the study.
5. Night-shifts or travel across time zones in the month preceding the study
6. Blood donation within 3 months prior to the start of the study
7. Smoking
8. More than 3 alcoholic beverages per day
9. Pre-existing, diagnosed psychiatric conditions or diagnosed anxiety
10. Excessive daytime sleepiness as assessed by the Epworth scale
11. Depression or anxiety as assessed by the Beck Depression Inventory and Beck Anxiety Inventory. Only a score in the range of 'normal ups and downs' (score 1-10) for depression or 'minimal anxiety' (score 0-7) for anxiety are tolerated.
12. History of addiction or excessive caffeine/alcohol consumption assessed by a questionnaire
13. Any other argument to believe that the subject is unlikely to successfully complete the full study protocol
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Chiel Poffé

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chiel Poffé, Dr.

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

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KU Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status

Countries

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Belgium

References

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Stalmans M, Tominec D, Robberechts R, Lauriks W, Ramaekers M, Debevec T, Poffe C. A Single Night in Hypoxia Either with or without Ketone Ester Ingestion Reduces Sleep Quality without Impacting Next-Day Exercise Performance. Med Sci Sports Exerc. 2025 Apr 1;57(4):807-819. doi: 10.1249/MSS.0000000000003604. Epub 2024 Nov 18.

Reference Type DERIVED
PMID: 39809236 (View on PubMed)

Other Identifiers

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S67089

Identifier Type: -

Identifier Source: org_study_id